510(k) · Cleared
Recalled · Class II · 2023Xpert Xpress Strep A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cleared on Sep 25, 2017 as substantially equivalent to K141338 (Iquum, Inc., 2014) after a 73-day review. Its family tree reaches back 2 generations to 2014. It has been recalled 2 times.
- Decided
- Sep 25, 2017
- Review
- 73 days
- Class
- Class II
- Product code
- PGX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN140005 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGX device
- #1 K260047 cobas Strep A Nucleic acid test for use on the…score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141338 | Liat Strep a AssaySummary page 4…crobiology (83) Advisory Panel Prescription Use Yes Predicate Device IQuum Roche Liat™ Strep A Assay Assay: [510(k) #K141338] Xpert Xpress Strep a 510(k) Page 1 Device Description: The… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2023 | Class II | Z-0215-2024 | Unknown/Undetermined by firm | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
| Apr 24, 2023 | Class II | Z-0216-2024 | Unknown/Undetermined by firm | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K141338.
How does its category compare?
All PGX devicesPGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PGX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PGX
85in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGX
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGX
1in 2022
MAUDE reports naming product code PGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | 85 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Xpert Xpress Strep A Assay, performed on the GeneXpert Instrument Systems, is a rapid, qualitative in vitro
diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus, Strep A) in throat
swab specimens from patients with signs and symptoms of pharyngitis.
The Xpert Xpress Strep A Assay utilizes an automated real-time polymerase chain reaction (PCR) to detect Streptococcus
pyogenes DNA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K172126: Xpert Xpress Strep A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172126
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026